Pharmaceutical Technology Europe-01-01-2008

How much do you know about parallel trade? Perhaps you may have heard someone mention these words and have then switched off. In a sense, it's hardly surprising given the fact that most media coverage centres on interpretation of complex legal cases. By the time you reach the end of these types of articles, you can't work out what the mentioned companies were arguing about in the first place and on which technical details the case was judged. Yet, time after time, a legal ruling on a parallel trade issue rockets to the front pages of the pharmaceutical press and even, occasionally, the mainstream media.

Although overall pharmaceutical industry investment in R&D in Spain is growing at a slower annual level since 2004, investment in clinical trials remains strong.

The pharmaceutical industry in Asia is gearing up to be at the centre of the global market. Most pharmaceutical companies in the region expect this shift to happen fast. Not only is Asia set to become the largest pharmaceutical market in the world, but many Asian territories will be the powerhouses of the industry. By 2020, the worldwide pharmaceuticals market could be worth around $1.3 trillion, with China being the second or third biggest market.

While it's unlikely that Al Gore's Nobel Peace Prize will gain him the US Presidency, the award has put global warming firmly in the spotlight (as if it wasn't there already). Reducing its carbon footprint is among the many goals Big Pharma has for the coming year - and beyond. Many energy consumption issues are common to all industries and individuals, such as putting curbs on business travel, bringing renewable energy sources on board and switching off lights in unoccupied rooms, but there are other issues that are specific to our industry. For example, asthma inhalers emit greenhouse gases and many pharmaceutical syntheses use toxic solvents.

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) recently closed consultation on its draft guidance, ICH Q10 Pharmaceutical Quality System. If all goes to plan, adoption could come as soon as Spring 2008.

The use of viral vectors as gene delivery and vaccine vehicles has developed rapidly during the last two decades owing to several viral properties. Viruses can infect cells efficiently, often have a broad tissue tropism and can achieve very high levels of either stable or transient transgene expression. Furthermore, their intrinsic immune-stimulatory properties can have adjuvant effects during the treatment of cancer or infectious disease and, importantly for manufacturing scale-up, some viruses can be grown to very high titre (.1012 particles/mL). The development of robust production procedures is essential to move therapeutics that utilize viral vectors into clinical trials, and to make them cost effective for market supply. Here, we describe some of the aspects of production that must be considered and optimized when producing virus vectors on an intermediate or large scale. By drawing examples from our experience of vector production, we show that upstream and downstream processes must be designed..

As the saying goes, actions speak louder than words, and I hope the features in this month's magazine provide you with examples of how others in the industry are playing their role in a greener future.

Historically, the main purpose of laboratory information management systems (LIMS) has been to track and manage samples in the laboratory. LIMS originated nearly 30 years ago as a rudimentary method of automating manual, error-prone processes in the laboratory and, with the growth in adoption of technology, became the de facto benchmark for laboratory control and management.

However, companies should always be prioritizing prevention, elimination and reduction over recycling and recovery as the most effective ways of making resource efficiency savings.

Forward-thinking manufacturers are recognizing the need for a more sustainable approach to containment design.

Getting a clear view of business performance can be cumbersome, time-consuming and even nigh-on impossible.